NCT00911768已完成4 期
PMS Clinical Study of Korean Red Ginseng Powder on Dry Mouth and Salivary Flow Rates in Xerostomatic Populations
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale of Subjective Dry Mouth
研究概览
简要总结
The purpose of this study is to determine the effect of KRG (Korean Red Ginseng) on Dry Mouth (Xerostomia).
详细描述
Korean Red Ginseng
- Worldwide use
- A main herb of old oriental prescriptions for dry mouth
- Need for correct information by RCT
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dry mouth patients
排除标准
- •Sjögren syndrome
- •Irradiation related xerostomia
- •Severe psychiatric diseases
- •pregnancy or breast feeding women
研究组 & 干预措施
Korean Red Ginseng group
Experimental
The brand name of experimental drug is 'Capsule of Korean Red Ginseng Powder'. It consists of the powder of steamed root of Panax ginseng made by Korean Ginseng Corp.
干预措施: Korean Red Ginseng Powder Capsule (Dietary Supplement)
Corn-starch powder with ginseng flavor
Placebo Comparator
The placebo of this study is corn-starch powder with Korean Red Ginseng flavor. It has the same shape, color and flavor like experimental drug.
干预措施: Corn-starch powder with ginseng flavor (Dietary Supplement)
结局指标
主要结局
Visual Analogue Scale of Subjective Dry Mouth
时间窗: 8 weeks
Visual Analogue Scale of Subjective Dry Mouth is 10 cm, where 0 cm indicates no dry mouth and 10 cm the severe dry mouth.
次要结局
- Stimulated Salivary Flow Rates(8 weeks)
- Unstimulated Salivary Flow Rates(8 weeks)
研究者
研究点 (1)
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